Princeton, NJ

Company Name:RCI Recruitment SolutionsSeeking a Hands-On Director of Regulatory Affairs. Apply today!My client is a biopharmaceutical company that is focused on developing breakthrough treatments for human disease. Lexicon has advanced multiple drug candidates into clinical development. They are presently devoting most of their resources to the development of their two most advanced drug candidates. LX4211 is an orally-delivered small molecule drug candidate developed as a treatment for type 1 and type 2 diabetes. They have completed two Phase 2 clinical trials of LX4211 in type 2 diabetes. Additionally, Lexicon is also developing telotristat etiprate (LX1032), an orally-delivered small molecule drug candidate as a treatment for characinoid syndrome. They are presently conducting a pivotal Phase 3 clinical trial of telotristat etiprate in patients.Director of Regulatory AffairsThe Woodlands, Texas and Princeton, New JerseyAs our clients Director of Regulatory Affairs, you will oversee the development of regulatory operations strategies and implementation of technical systems for regulatory operations aspects of pre-market and post-market products, filing of applications and interactions with health authorities pertaining to regulatory operations issues or inquires. The position is responsible for oversight and maintenance of existing IND/CTA submissions on assigned programs. This involves the preparation of all amendments and annual reports in compliance with FDA regulations. Additionally, the selected individual will be responsible for assisting with pre-IND meeting briefing packages and initial IND submissions for new programs; representing the department on multi-disciplinary development teams and supervising staff.To qualify, you should hold a Bachelors degree in Science, Chemistry or Biology and possess 8 or more years of focused experience in regulatory affairs working in the pharmaceutical/biotech industry. Extensive experience with regulatory strategy, IND and NDA submission experience, along with global regulatory experience are essential. Your background should also include extensive knowledge of global regulatory requirements with a strong focus on US, EU and ICH requirements, face to face meetings with the FDA, proven experience with Electronic Document Management systems, and the management and development of staff.Working with my client, you will earn a competitive salary, and a generous benefits package including medical, dental, vision, AD&D and life insurance, retirement plan, educational assistance programs, paid time off, plus the ability to be part of team who is changing the landscape of medicine and making a difference in patients lives.Please send your resume to , for immediate consideration.Our Client is an Equal Opportunity Employer.RCI Recruitment Solutions is a privately owned firm headquartered in Jupiter, Florida, with operations throughout the United States. For almost 40 years, RCI has provided a wide range of candidate sourcing and related recruitment services. Its proprietary and client-specific solutions encompass a variety of services, including advertising, consulting, media services, and staffing technology.

The fraudster will send a check to the victim who has accepted a job. The check can be for multiple reasons
such as signing bonus, supplies, etc. The victim will be instructed to deposit the check and use the money
for any of these reasons and then instructed to send the remaining funds to the fraudster. The check will
bounce and the victim is left responsible.

We found Information Technology (IT) Jobs and educational opportunities for you.

Step 1 of 3: Fill out the form below.

First Name:

Last Name:

Email:

Zip:

Phone:

By clicking 'Continue', I declare that I am a U.S resident over 18, I agree to the
Privacy Policy
and Terms of Use,
I provide my consent and signature to have a representative from Career Advisor contact me regarding career and educational opportunities at the email and phone number provided, including wireless, using automated technology, pre-recorded calls and/or text messages, and my consent is not a condition of purchase. In addition, I agree to receive job alerts and special offers by email from you and your trusted partners.

By clicking 'Continue', I consent to be contacted regarding education opportunities at the phone number provided: , using an automated telephone dialing system and/or pre-recorded voice. I may be contacted by Career Advisor. Consent is not required as a condition of using this service.